Dosing & Uses
Dosage Forms & Strengths
tablet
- 0.125mg
- 0.25mg
- 0.5mg
- 0.75mg
- 1mg
- 1.5mg
tablet, extended release
- 0.375mg
- 0.75mg
- 1.5mg
- 2.25mg
- 3mg
- 3.75mg
- 4.5mg
Parkinson Disease
Immediate-release: 0.125 mg PO q8hr initially; gradually titrated upward at weekly intervals to target range of 1.5-4.5 mg/day PO divided q8hr
Extended-release: 0.375 mg/day PO initially; if necessary, may be increased every 5-7 days, first to 0.75 mg/day and then by increments of 0.75 mg/day; not to exceed 4.5 mg/day
Restless Legs Syndrome
0.125 mg/day PO 2-3 hr before bedtime initially; may be increased every 4-7 days up to 0.5 mg/day (every 14 days if CrCl 20-60 mL/min)
Dosage Modifications
Hepatic impairmet: No dosage adjustments provided in the manufacturer's labeling; adjustment not expected; undergoes minimal hepatic metabolism
Renal Impairment
Parkinson disease
Immediate release
- CrCl >50 mL/min: Dosage adjustment not necessary
- CrCl 30-50 mL/min: 0.125 mg twice daily initially; not to exceed 0.75 mg TID
- CrCl 15-29 mL/min: 0.125 mg qDay; not to exceed 1.5 mg qDay
- CrCl <15 mL/min: Dosage adjustment not provided in manufacturer's labeling; not studied
- ESRD requiring hemodialysis: Dosage adjustment not provided in manufacturer's labeling; not studied
Extended release
- CrCl >50 mL/min: Dosage adjustment not necessary
- CrCl 30-50 mL/min: 0.375 every other day; may increase to 0.375 mg qDay no sooner than 1 wk after initiating therapy; may increase by 0.375 mg/dose not more frequently than every 7 days; not to exceed 2.25 mg qDay
- CrCl <30 mL/min: Not recommended
- ESRD requiring hemodialysis: Not recommended
Restless legs syndrome
Immediate release
- CrCl >60 mL/min: Dosasge adjustment not necessary
- CrCl 20-60 mL/min: Dosage adjustment not necessary but duration between titration should be increased to 14 days
- CrCl<20 mL/min: Dosage adjustment not provided by manufacturer's labeling; not studied
Dosing Considerations
May switch overnight from immediate-release to extended-release tablets at same daily dose; dose adjustments may be required for some patients
Administration
Extended-release: Swallow whole; do not chew, crush, or divide
Discontinuing immediate- or extended-release: Taper off at a rate of 0.75 mg/day until the daily dose has been reduced to 0.75 mg; thereafter, the dose may be reduced by 0.375 mg/day
Dosage Forms & Strengths
tablet
- 0.125mg
- 0.25mg
- 0.5mg
- 0.75mg
- 1mg
- 1.5mg
tablet, extended release
- 0.375mg
- 0.75mg
- 1.5mg
- 2.25mg
- 3mg
- 3.75mg
- 4.5mg
Tourette Syndrome (Orphan)
Treatment of Tourette syndrome in pediatric patients
Orphan indication sponsor
- Boehringer-Ingelheim Pharmaceuticals, Inc; 900 Ridgebury Road; Ridgefield, CT 06877
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (27)
- amisulpride
amisulpride, pramipexole. Either decreases effects of the other by pharmacodynamic antagonism. Contraindicated. Avoid use of amisulpride, a dopamine receptor antagonist, with dopamine agonists.
- aripiprazole
aripiprazole decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- chlorpromazine
chlorpromazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- clozapine
clozapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- droperidol
droperidol decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- fluphenazine
fluphenazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- haloperidol
haloperidol decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- iloperidone
iloperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- loxapine
loxapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- loxapine inhaled
loxapine inhaled decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- metoclopramide
metoclopramide decreases levels of pramipexole by pharmacodynamic antagonism. Contraindicated.
- metoclopramide intranasal
pramipexole, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.
metoclopramide intranasal, pramipexole. dopaminergic effects. Avoid or Use Alternate Drug. Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (eg, parkinsonian symptoms) or decreased therapeutic effects of metoclopramide. - olanzapine
olanzapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- olopatadine intranasal
pramipexole and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- paliperidone
paliperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- perphenazine
perphenazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- pimozide
pimozide decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- prochlorperazine
prochlorperazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- promethazine
promethazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- quetiapine
quetiapine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- risperidone
risperidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- tafenoquine
tafenoquine will increase the level or effect of pramipexole by Other (see comment). Avoid or Use Alternate Drug. Tafenoquine inhibits organic cation transporter-2 (OCT2) and multidrug and toxin extrusion (MATE) transporters in vitro. Avoid coadministration with OCT2 or MATE substrates. If coadministration cannot be avoided, monitor for substrate-related toxicities and consider dosage reduction if needed based on product labeling of the coadministered drug.
- thioridazine
thioridazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- thiothixene
thiothixene decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- trifluoperazine
trifluoperazine decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
- trilaciclib
trilaciclib will decrease the level or effect of pramipexole by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.
- ziprasidone
ziprasidone decreases effects of pramipexole by pharmacodynamic antagonism. Contraindicated.
Monitor Closely (22)
- apomorphine
apomorphine and pramipexole both increase dopaminergic effects. Use Caution/Monitor.
- bromocriptine
bromocriptine and pramipexole both increase dopaminergic effects. Use Caution/Monitor. Combining drugs may be therapeutic in patients with Parkinsonism.
- cabergoline
cabergoline and pramipexole both increase dopaminergic effects. Use Caution/Monitor.
- cenobamate
cenobamate, pramipexole. Either increases effects of the other by sedation. Use Caution/Monitor.
- cimetidine
cimetidine will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.
- clobazam
pramipexole, clobazam. Other (see comment). Use Caution/Monitor. Comment: Concomitant administration can increase the potential for CNS effects (e.g., increased sedation or respiratory depression).
- clonidine
clonidine, pramipexole. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration enhances CNS depressant effects.
- daridorexant
pramipexole and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- difelikefalin
difelikefalin and pramipexole both increase sedation. Use Caution/Monitor.
- digoxin
digoxin will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.
- erdafitinib
erdafitinib increases levels of pramipexole by decreasing renal clearance. Modify Therapy/Monitor Closely. Consider alternatives that are not OCT2 substrates or consider reducing the dose of OCT2 substrates based on tolerability.
- levodopa
levodopa and pramipexole both increase dopaminergic effects. Use Caution/Monitor.
- lurasidone
lurasidone decreases effects of pramipexole by Other (see comment). Use Caution/Monitor. Comment: Antipsychotics may diminish the therapeutic effect of anti-parkinson's agents; may increase riskof hypotension.
lurasidone, pramipexole. Either increases toxicity of the other by sedation. Use Caution/Monitor. Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity. - methyldopa
methyldopa and pramipexole both increase dopaminergic effects. Use Caution/Monitor.
- methylphenidate
pramipexole, methylphenidate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Potential for additive CNS stimulation.
- midazolam intranasal
midazolam intranasal, pramipexole. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
- procainamide
pramipexole will increase the level or effect of procainamide by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.
- quinidine
quinidine will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor.
- ropinirole
pramipexole and ropinirole both increase dopaminergic effects. Use Caution/Monitor.
- solriamfetol
pramipexole and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.
- stiripentol
stiripentol, pramipexole. Either increases effects of the other by sedation. Use Caution/Monitor. Concomitant use stiripentol with other CNS depressants, including alcohol, may increase the risk of sedation and somnolence.
- tenofovir DF
tenofovir DF increases levels of pramipexole by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
Minor (6)
- isavuconazonium sulfate
isavuconazonium sulfate will increase the level or effect of pramipexole by Other (see comment). Minor/Significance Unknown. Isavuconazonium sulfate, an OCT2 inhibitor, may increase the effects or levels of OCT2 substrates.
- memantine
memantine will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- methyclothiazide
methyclothiazide will increase the level or effect of pramipexole by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- quinine
pramipexole will increase the level or effect of quinine by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- triamterene
pramipexole will increase the level or effect of triamterene by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.
- verapamil
pramipexole will increase the level or effect of verapamil by basic (cationic) drug competition for renal tubular clearance. Minor/Significance Unknown.
Adverse Effects
Some variations between early Parkinson, advanced Parkinson, and restless legs syndrome
Incidence of some adverse drug reactions (eg, dizziness, accidental injury) >10% but comparable to placebo
>10%
Somnolence
Dyskinesia
Hallucinations
Insomnia
Dizziness
Postural hypotension
Nausea
Constipation
1-10% (partial list)
Abnormal dreams, thoughts, or vision
Amnesia
Confusion
Paranoia or delusion
Akathisia
Asthenia
Dry mouth
Urinary frequency
Postmarketing Reports
Neurologic: Abnormal behavior, abnormal dreams, compulsive shopping, fatigue, hallucinations (all kinds), headache, pathologic gambling
Cardiovascular: Hypotension (including syncope and postural hypotension)
Metabolic: Increased eating (including binge eating, compulsive eating, and hyperphagia), weight gain, SIADH
Dermatologic: Skin reactions, including rythema, rash, pruritus, urticaria
Gastrointestinal: Vomiting
Genitourinary: Libido disorders (including increased or decreased libido and hypersexuality)
Withdrawal symptoms
Warnings
Contraindications
Hypersensitivity
Cautions
May cause sudden daytime "sleep attacks;" inquire about factors that may increase risk of falling asleep, including sleep disorders or taking sedating medications; caution patients about performing tasks requiring mental alertness; discontinue if there is evidence of sleep attacks; if decision is made to continue therapy, advice patient not to perform dangerous activities requiring mental alertness
Orthostatic hypotension may occur, particularly during dose escalation; monitor closely Parkinson patients being treated with dopaminergic agonists, especially during dose escalation
In early Parkinson, dosages higher than 1.5 mg q8hr provided no additional benefit but increased adverse events
Use with caution in renal impairment; dose adjustment may be necessary; do not administer extended release tablets to patients with CrCl<30 mL/min or ESRD requiring hemodialysis
Augmentation or rebound of restless legs syndrome (RLS) may occur with therapy in RLS patients
The elderly may be more prone to adverse effects
Swallow whole; do not chew, crush, or divide extended release tablets
Events reported with dopaminergic therapy include hyperpyrexia and confusion
Fibrotic complications reported with use; monitor closely for signs and symptoms of fibrosis; discontinuation of therapy may resolve complications but not in all cases
Rsk of melanoma increases in Parkinson disease patients; monitor closely and perform periodic skin examination
Pathologic degenerative changes observed in retinas of albino rats during studies; significance in humans unclear
May cause or exacerbate dyskinesia; use with caution in patients with preexisting dyskinesias
Symptoms resembling neuroleptic malignant syndrome, including elevated temperature, muscular rigidity, altered consciousness, and autonomic instability reported with rapid dose reduction, discontinuation, or changes in therapy; taper dose to decrease risk of hyperpyrexia and confusion
Risk of new-onset heart failure undergoing FDA evaluation (FDA safety announcement 9/19/2012)
Withdrawal symptoms
- Gradual discontinuance required over period of 1 week or longer; symptoms resembling neuroleptic malignant syndrome may occur on abrupt withdrawal
- Symptoms including apathy, anxiety, depression, fatigue, insomnia, sweating, and pain reported during taper or after discontinuation of dopamine agonists; these symptoms generally do not respond to levodopa
- Prior to discontinuation, patients should be informed about potential withdrawal symptoms, and monitored during and after discontinuation; in case of severe withdrawal symptoms, a trial re-administration of a dopamine agonist at lowest effective dose may be considered
Psychiatric effects
- Patients can experience intense urges to gamble, increased sexual urges, intense urges to spend money uncontrollably, binge eating, and/or other intense urges and the inability to control these urges while taking one or more of the medications, that increase central dopaminergic tone
- Patients may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during treatment or after starting or increasing the dose
- Other drugs prescribed to improve the symptoms of Parkinson’s disease or RLS can have similar effects on thinking and behavior; this abnormal thinking and behavior can consist of one or more of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behavior, symptoms of mania (eg, insomnia, psychomotor agitation), disorientation, aggressive behavior, agitation, and delirium
- Risk increases with age; dose reduction or discontinuation may reverse these behaviors but not in all cases
Pregnancy & Lactation
There are no adequate data on the developmental risk associated with therapy in pregnant women; no adverse developmental effects reported in animal studies in which pramipexole was administered to rabbits during pregnancy; effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures
In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively; background risk of major birth defects and miscarriage for the indicated population is unknown
Lactation: Not known if drug secreted in breast milk; may inhibit milk production; discontinue drug, or do not nurse
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Non-ergot dopamine D2 receptor agonist; strong affinity for D2 and D3 receptors; binding to these receptors increases dopamine activity on nerves of striatum and substantia nigra
Absorption
Bioavailability: >90%
Peak plasma time: Immediate release, 2 hr; extended release, 6 hr
Distribution
Protein bound: 15%
Vd: 500 L
Metabolism
<10% metabolized
Elimination
Half-life: 8.5 hr (12 hr in elderly)
Renal clearance: 400 mL/min
Excretion: Urine (90%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Mirapex ER oral - | 3.75 mg tablet |  | |
| Mirapex ER oral - | 2.25 mg tablet |  | |
| Mirapex ER oral - | 0.75 mg tablet |  | |
| Mirapex ER oral - | 4.5 mg tablet |  | |
| Mirapex ER oral - | 1.5 mg tablet |  | |
| Mirapex ER oral - | 3 mg tablet |  | |
| Mirapex ER oral - | 0.375 mg tablet |  | |
| pramipexole oral - | 1 mg tablet |  | |
| pramipexole oral - | 0.5 mg tablet |  | |
| pramipexole oral - | 0.25 mg tablet |  | |
| pramipexole oral - | 0.125 mg tablet |  | |
| pramipexole oral - | 0.5 mg tablet |  | |
| pramipexole oral - | 1 mg tablet |  | |
| pramipexole oral - | 1 mg tablet |  | |
| pramipexole oral - | 0.25 mg tablet |  | |
| pramipexole oral - | 0.125 mg tablet |  | |
| pramipexole oral - | 0.125 mg tablet |  | |
| pramipexole oral - | 3.75 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 4.5 mg tablet |  | |
| pramipexole oral - | 0.75 mg tablet |  | |
| pramipexole oral - | 3 mg tablet |  | |
| pramipexole oral - | 0.375 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 0.75 mg tablet |  | |
| pramipexole oral - | 0.25 mg tablet |  | |
| pramipexole oral - | 0.375 mg tablet |  | |
| pramipexole oral - | 1 mg tablet |  | |
| pramipexole oral - | 0.5 mg tablet |  | |
| pramipexole oral - | 0.25 mg tablet |  | |
| pramipexole oral - | 0.125 mg tablet |  | |
| pramipexole oral - | 0.75 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 1 mg tablet |  | |
| pramipexole oral - | 0.5 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 4.5 mg tablet |  | |
| pramipexole oral - | 2.25 mg tablet |  | |
| pramipexole oral - | 0.75 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 3.75 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 0.75 mg tablet |  | |
| pramipexole oral - | 0.5 mg tablet |  | |
| pramipexole oral - | 0.125 mg tablet |  | |
| pramipexole oral - | 2.25 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 3 mg tablet |  | |
| pramipexole oral - | 0.25 mg tablet |  | |
| pramipexole oral - | 1.5 mg tablet |  | |
| pramipexole oral - | 0.375 mg tablet |  | |
| Mirapex oral - | 1 mg tablet |  | |
| Mirapex oral - | 0.125 mg tablet |  | |
| Mirapex oral - | 1.5 mg tablet |  | |
| Mirapex oral - | 0.5 mg tablet |  | |
| Mirapex oral - | 0.25 mg tablet |  | |
| Mirapex oral - | 0.75 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
pramipexole oral
PRAMIPEXOLE EXTENDED-RELEASE - ORAL
(PRAM-i-PEX-ole)
COMMON BRAND NAME(S): Mirapex
USES: Pramipexole is used alone or with other medications to treat Parkinson's disease. It can improve your ability to move and can decrease shakiness (tremor), stiffness, slowed movement, and unsteadiness. It may also decrease the number of episodes of not being able to move ("on-off syndrome").Pramipexole is a dopamine agonist that works by helping to restore the balance of a certain natural substance (dopamine) in the brain.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking pramipexole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Swallow this medication whole. Do not crush, chew, or break the tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Taking this medication with food may lessen nausea. To reduce your risk of side effects (such as drowsiness, low blood pressure), your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Do not increase your dose or take it more often than directed.Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this medication is suddenly stopped. Also, if you suddenly stop using this medication, you may have withdrawal symptoms (such as anxiety, depression, confusion, fever, muscle stiffness). To help prevent withdrawal, your doctor may lower your dose slowly. Withdrawal is more likely if you have used pramipexole for a long time or in high doses. Tell your doctor or pharmacist right away if you have withdrawal.If you temporarily stop taking this medication, you may need to start this medication again at a low dose and gradually increase your dose. Talk with your doctor about how to restart this medication.It may take a few weeks for the effects of this medication to be noticed. Tell your doctor if your condition does not get better or if it gets worse.
SIDE EFFECTS: See also How to Use section.Nausea, vomiting, dizziness, drowsiness, lightheadedness, trouble sleeping, constipation, headache, cough, or dry mouth may occur. If these effects last or get worse, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Tell your doctor if you see a swollen tablet or pieces of a tablet in your stool.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, agitation, hallucinations), unusual strong urges (such as increased gambling, increased sexual urges), muscle cramps/spasm, unusual posture changes (such as the neck or body bending forward), swelling of the ankles/feet.Get medical help right away if you have any very serious side effects, including: chest pain, trouble breathing, muscle pain/weakness, unusual tiredness, signs of kidney problems (such as change in the amount of urine), vision changes.Some people taking pramipexole have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with pramipexole even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. See also Precautions section.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking pramipexole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: low blood pressure, heart problems (such as irregular heartbeat, heart failure), kidney problems, mental/mood disorders (such as confusion, hallucinations, psychosis, schizophrenia), sleep disorder (such as sleep apnea, narcolepsy).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be at a greater risk for dizziness and hallucinations while using this drug.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). See also Side Effects section.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This drug may pass into breast milk and could have undesirable effects on a nursing infant. It may also affect milk production. Breastfeeding is not recommended while using this drug. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: antipsychotics (such as chlorpromazine, haloperidol, thiothixene), cimetidine, metoclopramide.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.
MISSED DOSE: If you miss a dose and it is within 12 hours of the time you usually take the dose, take it as soon as you remember. If it is more than 12 hours from the time you usually take the dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised October 2023. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
